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Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
|
| Placebo | Placebo Comparator | Placebo (identical to low dose aspirin (100 mg)) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of preeclampsia | The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of preeclampsia at term | The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy. | 6 months |
| Stillbirth | The number of cases of stillbirths that appear in both groups at any given time during pregnancy. |
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Inclusion Criteria:
Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index > 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo Velarde, MD | Contact | revelarde_14@yahoo.es | ||
| Osvaldo Reyes, MD | Contact | oreyespanama@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Osvaldo Reyes, MD | Saint Thomas Maternity Hospital | Principal Investigator |
| Rodrigo Velardee, MD | Saint Thomas Maternity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Thomas Maternity Hospital | Panama City | Panama |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D005317 | Fetal Growth Retardation |
| D066087 | Perinatal Death |
| D050497 | Stillbirth |
| D000037 | Abruptio Placentae |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night. |
|
| 6 months |
| Neonatal deaths | The number of cases of neonatal deaths that appear in both groups, regardless of the cause. | 6 months |
| Neonatal intensive care unit admissions. | The number of cases that require admittance to the Neonatal Intensive Care Unit in both groups in the first 28 days after birth. | 28 days |
| Abruptio placenta | The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy. | 6 months |
| Fetal Growth Restriction | The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy. | 6 months |
| Ameth Hawkins, MD |
| Saint Thomas Maternity Hospital |
| Principal Investigator |
| Ana Moreno, MD | Saint Thomas Maternity Hospital | Principal Investigator |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003643 | Death |
| D005313 | Fetal Death |
| D007744 | Obstetric Labor Complications |
| D010922 | Placenta Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |